BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 12 FR X 20 CM

    MDR report key: 4862194 · Received June 23, 2015

    Report

    Report Number
    1036844-2015-00266
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 14, 2015
    Report Date
    June 15, 2015
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED COMPLAINT WAS CONFIRMED THROUGH EXAMINATION OF A RETURNED PRODUCT SAMPLE. THE CUSTOMER PROVIDED A GUIDE WIRE THAT HAD SEPARATED INTO TWO PIECES. THE DISTAL SECTION HAD 3 KINKS. THE PROXIMAL SECTION HAD 4 KINKS. NO PIECES OF THE WIRE APPEARED TO BE MISSING. SINCE THE COILS OF THE SWG WERE NOT UNRAVELED NEAR THE SEPARATION, IT APPEARS THAT THE SPRING WIRE GUIDE WAS CUT AND NOT SEPARATED BY FORCE. IT IS NOT KNOWN IF THE SEPARATION OCCURRED DURING THE PROCEDURE OR AFTERWARD. THE RETURNED DILATOR WAS OBSERVED TO BE BENT AND BLOCKED WITH DRIED BLOOD. THIS INDICATES THAT THE SPRING WIRE GUIDE HAD BEEN INSERTED INTO THE VESSEL AND THE INSERTION COMPONENTS WERE REMOVED BEFORE DILATION. A REVIEW OF MANUFACTURING RECORDS DID NOT YIELD ANY RELEVANT FINDINGS. SINCE THE DAMAGE TO THE SPRING WIRE GUIDE WAS OBSERVED UPON REMOVAL, OPERATIONAL CONTEXT APPEARS TO HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. IT DOES NOT APPEAR THAT THE SPRING WIRE GUIDE WAS SEPARATED BY CONTACT WITH THE NEEDLE BEVEL. THE INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT THE SPRING WIRE GUIDE WAS FOUND KINKED UPON WITHDRAWAL AND DOES NOT MENTION SEPARATION. THEREFORE, THE PROBABLE CAUSE OF THE GUIDE WIRE SEPARATION COULD NOT BE DETERMINED. NO FURTHER ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION IN HD, THE PHYSICIAN COULD NOT SMOOTHLY ADVANCE THE GUIDE WIRE. THE GUIDE WIRE WAS OBSERVED TO BE KINKED. AS A RESULT, A NEW KIT WAS OPENED AND USED WITHOUT ISSUE. A DELAY WAS REPORTED, HOWEVER, THERE WAS NO ADDITIONAL HARM TO THE PATIENT DUE TO THIS DELAY OR AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404928 CVC SET: 3-LUMEN 12 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC. 23F14D0776

    Patients

    Seq Age Sex Outcome Treatment
    1